(59 days)
The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs.
The Digital ClarusScope System and Digital NeuroPEN System are spinal endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for spinal procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application; the other fitting is an irrigation extension tube with a female Luerlock connector.
The provided text is a 510(k) summary for the Clarus Medical Digital ClarusScope System and Digital NeuroPEN System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information regarding specific performance acceptance criteria or detailed study results for proving the device meets these criteria. It lists various tests performed (e.g., performance testing, sterility, biocompatibility, electrical safety) but does not provide quantitative results, sample sizes, ground truth establishment, or details about expert involvement that would be needed to fill out the requested table and answer the study-related questions.
Therefore, I cannot populate the table or answer the specific questions about the study design as the information is not present in the provided document.
A 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed report of clinical or non-clinical trials with specific performance metrics against pre-defined acceptance criteria. While it mentions system verification and validation through "performance testing," "simulated use test," etc., it does not disclose the details of these tests in a way that would allow for a comprehensive answer to your request.
Based on the provided text, I can only state that the information required to answer your questions is not available.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.